Market Newsdesk

TORONTO and HOUSTON, Sept. 30, 2022 (GLOBE NEWSWIRE) — Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (NASDAQ: MDNA TSX: MDNA), a clinical stage immunotherapy company, today announced that it has received conditional approval from the Toronto Stock Exchange to extend the expiry date of the common share purchase warrants of the Company (the “Warrants”) originally issued on October 17, 2019. The Warrants, of which 1,549,052 are available to be extended, are exercisable for common shares of the Company (the “Common Shares”) at a price of $1.75 per Common Share and are set to expire on October 17, 2022.

The Company has extended the expiry date of such Warrants by an additional nine months to July 17, 2023, with such extension being effective on October 17, 2022 (the “Effective Date”). All other terms of the Warrants, including the exercise price, remain unchanged.

There are 1,661,552 Warrants remaining available for exercise including 112,500 Warrants held directly or indirectly by insiders of the Company which will not be extended.

About Medicenna

Medicenna is a clinical stage immunotherapy company focused on the development of novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first in class Empowered Superkines. Medicenna’s long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior CD122 (IL-2 receptor beta) binding without CD25 (IL-2 receptor alpha) affinity thereby preferentially stimulating cancer killing effector T cells and NK cells. Medicenna’s early-stage BiSKITs™ program, (Bifunctional SuperKine ImmunoTherapies) is designed to enhance the ability of Superkines to treat immunologically “cold” tumors. Medicenna’s IL-4 Empowered Superkine, MDNA55, has been studied in 5 clinical trials including a Phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. MDNA55 has obtained Fast-Track and Orphan Drug status from the FDA and FDA/EMA, respectively.

Forward-Looking Statements

This news release contains forward-looking statements under applicable securities laws and relate to the future operations of the Company and other statements that are not historical facts including, but not limited to, statements related to the extension of the term of the Warrants. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects”, “believes”, “seeks” and similar expressions. All statements other than statements of historical fact, included in this release, are forward-looking statements that are subject to risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the risks detailed in the annual information form and Form 20-F of the Company and in other filings made by the Company with the applicable securities regulators from time to time in Canada and the United States.

The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date hereof and except as required by law, we do not intend and do not assume any obligation to update or revise publicly any of the included forward-looking statements.

Further Information

For further information about the Company please contact:

Elizabeth Williams, Chief Financial Officer, 416-648-5555, [email protected]  

Investor Contact

For more investor information, please contact:

Dan Ferry, Managing Director, LifeSci Advisors, 617-430-7576, [email protected] 

September 30, 2022

Amsterdam, the Netherlands –

Royal Philips
(NYSE: PHG, AEX: PHIA) announced that today’s Extraordinary General Meeting of Shareholders (EGM) appointed Roy Jakobs as the company’s next President and Chief Executive Officer, effective October 15, 2022, succeeding current President and Chief Executive Officer Frans van Houten.

“I am very pleased that Roy Jakobs has been appointed today as the next CEO of Philips,” said Feike Sijbesma, Chairman of the Supervisory Board of Royal Philips. “On behalf of the entire Supervisory Board, I would like to thank Frans for successfully leading Philips’ transformation into a focused, global solutions leader in health technology. We are convinced that Roy is the right successor to lead Philips’ efforts to help improve the health and well-being of people globally, and further shape the company for increased value creation for shareholders and all other stakeholders.”

“I have enjoyed and feel deeply privileged for having been given the opportunity to shape Philips onto a path of future relevance as we embraced health and healthcare innovation as our company focus,” said Frans van Houten, CEO of Royal Philips. “Much has been achieved in the past 12 years and I want to thank the many passionate, talented colleagues who have made this possible. Nevertheless,  much remains to be done, and this will now be the task of the Executive Committee under the leadership of my successor. I wish Roy and the team much success.”

“I am honored to be appointed as the next CEO of Philips, and together with our Philips colleagues continue to help improve people’s health and well-being with meaningful innovations,“ said Roy Jakobs, incoming CEO of Royal Philips. “Philips is a unique company with a strong brand, more than 130 years of innovation power and a bright future as a leader in health technology solutions. I look forward to leading the company in a transparent way, empowering our people as we address the current challenges, while also shaping the next chapter of Philips.”

Additional information on the composition of Philips’ Board of Management and the Executive Committee can be found here.

For more information about the EGM, please click on this link.

For further information, please contact:

Elco van Groningen
Philips Global Press Office
Tel.: +31 6 8103 9584
E-mail: [email protected]

Derya Guzel
Philips Investor Relations
Tel.: +31 20 59 77055
E-mail: [email protected]

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2021 sales of EUR 17.2 billion and employs approximately 79,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

Attachments

• Roy Jakobs
• Frans van Houten
• CEO Frans van Houten congratulates incoming CEO Roy Jakobs on his appointment
• Incoming CEO Roy Jakobs introduces himself to the shareholders

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Transactions to create a precision genetic medicine company focused on neuromuscular and cardiac rare diseases, led by industry veteran and current AavantiBio CEO, Bo Cumbo –

– Strong synergies expected by combining key assets, including product candidates for Duchenne muscular dystrophy, Friedreich’s ataxia, BAG3 mediated dilated cardiomyopathy and other undisclosed cardiac diseases, novel capsid libraries, and personnel –

– Combined company is expected to have approximately $215 million in cash and investments, which is expected to fund the combined company into 2025 and support attainment of key milestones for lead gene therapy programs –

– Companies to Host Conference Call today, September 30, 2022 at 8:00 AM ET –

CHARLESTOWN, Mass. and CAMBRIDGE, Mass., Sept. 30, 2022 (GLOBE NEWSWIRE) — Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), and AavantiBio, Inc., a privately-held gene therapy company focused on transforming the lives of patients with Friedreich’s ataxia and rare cardiomyopathies, today announced that the companies have entered into a definitive merger agreement whereby Solid will acquire AavantiBio, including its pipeline assets and net cash. The combined company will focus on advancing a portfolio of neuromuscular and cardiac programs, led by SGT-003, a differentiated gene transfer candidate, for the treatment of Duchenne. Additional pipeline programs include AVB-202, a gene transfer candidate for the treatment of Friedreich’s ataxia, AVB-401 for BAG3 mediated dilated cardiomyopathy, and additional assets for the treatment of undisclosed cardiac diseases. Following approval by Solid stockholders, the combined company will operate as Solid Biosciences, will trade on Nasdaq under the ticker symbol “SLDB” and Bo Cumbo, the current Chief Executive Officer of AavantiBio, will assume the role of President and CEO of Solid Biosciences.

In support of the acquisition, Solid announced it has entered into a securities purchase agreement with a select group of institutional investors and accredited investors for a $75 million private placement that is expected to close concurrently with the closing of the merger. The private placement is being led by existing investors Perceptive Advisors, LLC, RA Capital Management and Bain Capital Life Sciences, and other new and existing investors participating in the private placement include CaaS Capital Management, Invus, Laurion Capital Management and Pura Vida Investments.

Immediately following the closing of the merger and financing, the total cash and investments of the combined company is expected to be approximately $215 million. Solid expects this will be sufficient to fund the combined company’s planned operating expenses and capital expenditure requirements into 2025 and enable the potential attainment of key milestones for the combined company’s lead programs. The merger and private placement are expected to close in the fourth quarter of 2022, subject to customary closing conditions.

“I created Solid with my wife, Annie, and our co-founders nearly ten years ago, to bring meaningful treatment options to patients and families who, like ours, live with the devastating consequences of Duchenne muscular dystrophy,” said Ilan Ganot, President, Chief Executive Officer and Co-Founder of Solid Biosciences. “This acquisition provides exciting opportunities to bring our potentially best-in-class Duchenne gene transfer candidate, SGT-003, to patients and to expand our portfolio with innovative gene therapies designed to address significant unmet need in additional, adjacent rare disease indications. Bo Cumbo will assume the role of President and CEO and is a seasoned biotech executive with extensive expertise in bringing products through development and commercialization. I look forward to helping Bo with the leadership transition following the acquisition, and I am grateful to the investors who continue to support Solid’s critical efforts.”

“I am excited for the opportunity to lead Solid Biosciences and to help build a leading genetic medicine company with a focus on neuromuscular and cardiac rare diseases,” said Bo Cumbo, President and Chief Executive Officer of AavantiBio. “The Solid team has done incredible work in advancing Duchenne gene therapy, and its commitment to the Duchenne community aligns with AavantiBio’s patient-centric mission of bringing new therapies that can positively improve the quality of life of rare disease patients and their families. I also look forward to advancing our library of next generation cardiac and skeletal muscle capsids to extend our opportunities to bring treatment options to more people in need.”

About The Combined Company Pipeline

The combined company will have a diversified pipeline across neuromuscular and cardiac diseases with indications Solid believes are characterized by high unmet need, clear mechanistic rationale and significant market opportunities.

Duchenne Muscular Dystrophy

Duchenne is a fatal neuromuscular disease caused by mutations in the gene encoding dystrophin that lead to the absence or near-absence of functional dystrophin protein. Today, Solid announced it has made the strategic decision to prioritize SGT-003, its next-generation adeno-associated virus (AAV) gene transfer therapy candidate that utilizes a rationally designed, novel muscle-tropic AAV capsid (AAV-SLB101), to deliver Solid’s proprietary and differentiated neuronal nitric oxide synthase (nNOS) microdystrophin protein. Solid also announced it will be pausing activities for its first-generation gene transfer therapy candidate SGT-001. Solid intends to complete currently ongoing SGT-001 preclinical and manufacturing activities in order to be in a position to reactive the program in the future, if desired.

Development activities for SGT-003 continue and Solid anticipates submitting an investigational new drug application (IND) for SGT-003 in mid-2023 and, subject to IND clearance, initiating patient dosing in late-2023.

Friedreich’s Ataxia (FA)

FA is a rare inherited neuromuscular disease that causes progressive nervous system damage and movement problems. AVB-202, AavantiBio’s lead AAV gene transfer therapy candidate in preclinical development, utilizes a dual route of administration to more rigorously target disease pathology. Preclinical data from three animal models, including mouse and nonhuman primate, supported preclinical proof of concept. Solid is anticipating an IND submission for AVB-202 in the second half of 2024.

BAG3 Mediated Dilated Cardiomyopathy
(BAG3) and Undisclosed Cardiac Diseases

BAG3 is a rare cardiac disease and is characterized by mutations in the BAG3 gene. Sufficient levels of functional BAG3 are required for healthy cardiac function. AavantiBio is currently developing AVB-401, a preclinical-stage product candidate, for the treatment of BAG3. Following the acquisition of AavantiBio, Solid will continue to develop AVB-401, as well as two early-stage cardiac programs initially developed by AavantiBio as part of its pipeline activities.

Next generation AAV capsid libraries for targeted tissue delivery

Solid will continue development programs for novel AAV capsids that are expected to enhance select tissue tropism for cardiac and skeletal muscle as well as reduce liver targeting. The first capsid screened in the Solid-based skeletal muscle library is AAV-SLB101, which is used in SGT-003 and has demonstrated increased expression and biodistribution compared with AAV9 in multiple preclinical studies. We believe this capsid has the potential to be used in other neuromuscular and cardiac indications. In addition, Solid plans to continue current AavantiBio efforts to develop novel AAV cardiac-targeted capsids that enhance select tissue tropism and reduce liver targeting.

About the Proposed Transactions, Management and Organization

Management and Organization

Following the closing of the transactions, Bo Cumbo, will be the President and Chief Executive Officer of the combined company, which will continue to operate as Solid Biosciences. The executive leadership team of the combined company will also include Stephen DiPalma, Interim Chief Financial Officer, Carl Morris, Ph.D., Chief Scientific Officer for Neuromuscular Diseases, Jenny Marlowe, Ph.D., Chief Scientific Officer for Friedreich’s Ataxia and Cardiac Pipeline, Roxana Donisa Dreghici, M.D., Head of Clinical Development, Jessie Hanrahan, Ph.D., Chief Regulatory Officer, Paul Herzich, Chief Technology Officer and Ty Howton, Chief Administrative Officer. Upon the closing of the transactions, Solid will add Bo Cumbo and Adam Koppel, M.D., Ph.D., managing director at Bain Capital Life Sciences to the board of directors. Ilan Ganot will continue to serve on Solid’s board of directors.

Transaction Details

Pre-combination equity holders of Solid are expected to own approximately 85% of the combined company and pre-combination equity holders of AavantiBio are expected to own approximately 15% of the combined company, subject to certain adjustments set forth in the merger agreement and in each case before giving effect to the private placement. The merger agreement has been unanimously approved by the Board of Directors of each company, and by the stockholders of AavantiBio. 

In the private placement, Solid agreed to sell 159,574,463 shares of common stock at a price of $0.47 per share, and upon the closing of the private placement, will receive gross proceeds of $75 million.

The securities to be sold in the private placement will not be registered under the Securities Act of 1933, as amended (Securities Act), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Solid has agreed to file a registration statement with the U.S. Securities and Exchange Commission (SEC) registering the resale of the shares of common stock issued in the acquisition and in the private placement no later than the 60th day after the closing of the private placement.

The acquisition and private placement are expected to close before the end of 2022 with the private placement closing as of immediately following the acquisition, subject to approval by the stockholders of Solid and the satisfaction of other customary closing conditions.

BofA Securities acted as the sole placement agent for the private placement made to institutional investors. Wilmer Cutler Pickering Hale and Dorr LLP is acting as legal counsel to Solid Biosciences. Sidley Austin LLP is acting as legal counsel to AavantiBio.

Conference Call Information

The companies will host a conference call today, September 30, 2022, at 8:00 a.m. ET, to discuss the transactions. A live webcast of the call will be available on Solid’s website at www.solidbio.com under the “News & Events” tab in the Investor Relations section, or by clicking here. Participants may also access the call by dialing 877-407-2991 (domestic) or 201-389-0925 (international) five minutes prior to the start of the call and providing the Conference ID 13733092.

The archived webcast will be available in the “News and Events” section of Solid’s website.

About Solid Biosciences Inc.

Solid Biosciences is a life sciences company focused on advancing transformative treatments to improve the lives of patients living with Duchenne. Disease-focused and founded by a family directly impacted by Duchenne, our mandate is simple yet comprehensive – work to address the disease at its core by correcting the underlying mutation that causes Duchenne with our gene therapy candidate and SGT-003. For more information, please visit www.solidbio.com.

About SGT-003

SGT-003 is Solid’s next-generation AAV gene transfer therapy candidate that utilizes a rationally designed, novel muscle-tropic AAV capsid, called AAV-SLB101, to deliver Solid’s proprietary and differentiated nNOS microdystrophin for the treatment of Duchenne. AAV-SLB101 has demonstrated enhanced muscle biodistribution and transgene expression, as well as reduced liver tropism, compared with AAV9 in in vivo mouse models and, utilizing a reporter transgene, non-human primate in vivo models. SGT-003 has correspondingly demonstrated higher levels of microdystrophin expression in vivo in the mdx mouse model of Duchenne and in vitro in human Duchenne cell lines. Solid is targeting an IND submission for SGT-003 in mid-2023.

About AavantiBio, Inc.

AavantiBio is a gene therapy company focused on advancing innovative gene therapies in areas of high unmet medical need, including a lead program in Friedreich’s ataxia, a rare inherited genetic disease that causes cardiac and central nervous system dysfunction, and programs in dilated or hypertrophic cardiomyopathies, and a next generation cardiac capsid library. The company benefits from strategic partnerships with the University of Florida’s Powell Gene Therapy Center and the MDA Care Center at UF Health where AavantiBio’s co-founders and renowned gene therapy researchers Barry Byrne, M.D., Ph.D. and Manuela Corti, P.T., Ph.D. maintain their research and clinical practices. Learn more at www.aavantibio.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding: future expectations, plans and prospects for Solid, AavantiBio and the combined company following the anticipated consummation of the proposed merger; the anticipated benefits of the merger; the anticipated timing of the merger and private placement; the anticipated milestones, business focus and pipeline of the combined company; the expected cash and investments of the combined company at closing of the transactions and the cash runway of the combined company; the excepted management team and board of directors of the combined company; Solid’s SGT-003 program, including expectations for filing an IND and initiating dosing; AavantiBio’s AVB-202 program and AVB-401 program, including expectations for filing an IND for AVB-202, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties associated with: completion of the proposed merger and private placement in a timely manner or on the anticipated terms or at all; the satisfaction (or waiver) of closing conditions to the consummation of the merger and the private placement, including with respect to the approval of Solid’s stockholders; the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the merger agreement or the private placement; the effect of the announcement or pendency of the merger on Solid’s or AavantiBio’s business relationships, operating results and business generally; the ability to recognize the anticipated benefits of the merger; the outcome of any legal proceedings that may be instituted against Solid or AavantiBio following any announcement of the proposed merger and related transactions; the ability to obtain or maintain the listing of the common stock of the combined company on the Nasdaq Stock Market following the proposed merger; risks related to Solid’s and AavantiBio’s ability to estimate their respective operating expenses and expenses associated with the transaction, as well as uncertainties regarding the impact any delay in the closing would have on the anticipated cash resources of the combined company upon closing and other events and unanticipated spending and costs that could reduce the combined company’s cash resources; costs related to the proposed merger, including unexpected costs, charges or expenses resulting from the merger; changes in applicable laws or regulation; the possibility that Solid or AavantiBio may be adversely affected by other economic, business and/or competitive factors; competitive responses to the transactions; risks related to Solid’s continued listing on the Nasdaq Global Select Market, including Solid’s ability to regain compliance with Nasdaq’s minimum bid price requirement; Solid’s ability to advance its SGT-003 program on the timelines expected or at all, obtain and maintain necessary approvals from the FDA and other regulatory authorities; following the merger, Solid’s ability to advance the programs acquired from AavantiBio, including the AVB-202 and AVB-401 programs, on the timelines expected or at all, obtain and maintain necessary approvals from the FDA and other regulatory authorities; obtaining and maintaining the necessary approvals from investigational review boards at clinical trial sites and independent data safety monitoring board; replicating in clinical trials positive results found in preclinical studies and early-stage clinical trials of product candidates; whether the methodologies, assumptions and applications utilized to assess particular safety or efficacy parameters will yield meaningful statistical results; advancing the development of product candidates under the timelines it anticipates in current and future clinical trials; successfully transitioning, optimizing and scaling Solid’s manufacturing process; obtaining, maintaining or protecting intellectual property rights related to Solid’s and AavantiBio’s product candidates; competing successfully with other companies that are seeking to develop Duchenne treatments, Friedreich’s ataxia, BAG3 and other gene therapies; managing expenses; and raising the substantial additional capital needed, on the timeline necessary, to continue development of SGT-003, AVB-202, AVB-401 and other product candidates; achieving Solid’s other business objectives and continuing as a going concern. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Solid’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in Solid’s most recent filings with the SEC. In addition, the forward-looking statements included in this press release represent Solid’s views as of the date hereof and should not be relied upon as representing Solid’s views as of any date subsequent to the date hereof. Solid anticipates that subsequent events and developments will cause Solid’s views to change. However, while Solid may elect to update these forward-looking statements at some point in the future, Solid specifically disclaims any obligation to do so.

No Offer or Solicitation

This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination and shall not constitute an offer to sell or a solicitation of an offer to buy any securities nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Important Additional Information Will Be Filed with the SEC

In connection with the merger and the private placement, Solid intends to file with the SEC preliminary and definitive proxy statements relating to the merger and the private placement and other relevant documents. The definitive proxy statement will be mailed to Solid’s stockholders as of a record date to be established for voting on the shares to be issued in the merger and the private placement and any other matters to be voted on at the special meeting. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PRELIMINARY AND DEFINITIVE PROXY STATEMENTS, ANY AMENDMENTS OR SUPPLEMENTS THERETO AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE MERGER OR THE PRIVATE PLACEMENT OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENTS WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT SOLID, AAVANTIBIO, THE MERGER AND THE PRIVATE PLACEMENT. Investors and security holders may obtain free copies of these documents (when they become available) on the SEC’s website at www.sec.gov, on Solid’s website at www.solidbio.com or by contacting Solid’s Investor Relations via email at [email protected] or by telephone at 607-423-3219.

Participants in the Solicitation

Solid, AavantiBio and their respective directors and executive officers may be deemed participants in the solicitation of proxies from the stockholders of Solid in connection with the issuance of shares in merger and the private placement and any other matters to be voted on at the special meeting. Information about Solid’s directors and executive officers is included in Solid’s most recent definitive proxy statement filed with the SEC on April 28, 2022. Additional information regarding the names, affiliations and interests of Solid’s and AavantiBio’s directors and executive officers will be included in the preliminary and definitive proxy statements (when filed with the SEC).

These documents (when filed with the SEC) will be available free of charge as described above.

Solid Biosciences
Investor and Media Contact:

Caitlin Lowie
Solid Biosciences
607-423-3219
[email protected]

AavantiBio Media Contact:

Scott Lessne
Stanton
(646) 502-3569
[email protected]   

Wellution™ offers dozens of products including natural supplements, creams, gels and hemp-based products on Amazon.com Marketplace

TEL AVIV, Israel, Sept. 30, 2022 (GLOBE NEWSWIRE) — SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced the closing of the definitive agreements for its acquisition of Wellution™, a top- seller Amazon.com Marketplace (“Amazon”) account, American food supplements and cosmetics brand and trademark (the “Acquisition” and the “Brand”, respectively). In connection with the Acquisition, the Company has incorporated a new wholly owned Delaware subsidiary, SciSparc Nutraceuticals Inc., to hold the new assets. The definitive agreement for the acquisition of the Brand was entered into with Merhavit M.R.M Holding and Management Ltd (“M.R.M”).

Wellution™ sells dozens of hemp-based, top-ranked products, including hemp gummies, hemp oil capsules, hemp gel, hemp cream, detox pills, height pills, antibacterial creams, and anti-aging creams, among other beauty and hair treatment products that are all manufactured in the United States.

Wellution™ offers eight variations of natural hemp candy supplements under two parent ASINs (Amazon Standard Identification Number) on Amazon that are differentiated by their hemp oil potency. The leading parent ASIN, that was launched in 2019, has received over 26,500 reviews and since its launch has consistently been ranked as the #1 best seller in its category on Amazon. In total, the Brand has over 40,000 product reviews, a majority of which are 4 and 5-star reviews.

At the closing, SciSparc paid a base cash payment of $4.59 million and in 12 months will pay an additional deferred cash payment equal to a multiple of 3 times the amount by which the Brand’s EBITDA* exceeds $1.12 million during the 12 month period following the closing of the Acquisition.

In addition, the Company issued to M.R.M $15 million worth of warrants to purchase ordinary shares of SciSparc at an exercise price of $7.00 per share (with a cashless exercise mechanism) and with an exercise period of five years from the closing of the Acquisition (the “Warrants”). The Warrants will become exercisable upon the achievement of a milestone of $100 million of sales of the Brand in the aggregate or if the price of SciSparc’s ordinary shares closes at $10.00 or above.

* Defined in the applicable definitive agreement as SDE and includes certain adjustments such as Research & Development expenses.

About SciSparc Ltd. (Nasdaq: SPRC):

SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive cannabidiol (CBD): SCI-110 for the treatment of Tourette Syndrome, for the treatment of Alzheimer’s disease and agitation; SCI-160 for the treatment of pain; and SCI-210 for the treatment of autism spectrum disorder and status epilepticus.

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc is using forward-looking statements when it discusses potential future cash payments and the exercisability of warrants with respect to the acquisition described above. Because such statements deal with future events and are based on SciSparc’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward- looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in SciSparc’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on April 28, 2022, and in subsequent filings with the SEC. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Investor Contact:




[email protected]


Tel: +972-3-6167055

THE WOODLANDS, Texas, Sept. 30, 2022 (GLOBE NEWSWIRE) — ChampionX Corporation (“ChampionX” or the “Company”) (NASDAQ: CHX) announced today that it will release its third quarter 2022 operating results on Tuesday, October 25, 2022, after the market closes. The Company has scheduled a conference call for Wednesday, October 26, 2022, at 8:00 a.m. Central Time (9:00 a.m. Eastern Time) to discuss the results.

The call will be available by live webcast on ChampionX’s website at https://investors.championx.com or by dialing in as follows:

United States:	1-866-374-5140
International:	1-404-400-0571
Reference:	ChampionX conference call number 45782469

Please register for the webcast or dial into the call approximately 15 minutes prior to the scheduled start time.

A replay of the conference call will be available for approximately 30 days on ChampionX’s website or at ChampionXThirdQuarter2022CallReplay. Enter passcode EV00137327.

About ChampionX

ChampionX is a global leader in chemistry solutions, artificial lift systems, and highly engineered equipment and technologies that help companies drill for and produce oil and gas safely, efficiently, and sustainably around the world. ChampionX’s expertise, innovative products, and digital technologies provide enhanced oil and gas production, transportation, and real-time emissions monitoring throughout the lifecycle of a well. To learn more about ChampionX, visit our website at www.championX.com.

Investor Contact:
Byron Pope – [email protected] – 281-602-0094

Media Contact:
John Breed – [email protected] – 281-403-3751

CAMBRIDGE, Mass., Sept. 30, 2022 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for BIIB800, a biosimilar candidate referencing RoACTEMRA^®1 (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody. RoACTEMRA^® is indicated in Europe as an intravenous formulation for severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate, moderate to severe rheumatoid arthritis in adults who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists, as well as for the treatment of patients from 2 years of age with juvenile idiopathic polyarthritis who have responded inadequately to previous therapy with methotrexate, patients from 2 years of age with active systemic juvenile idiopathic arthritis who have responded inadequately to prior therapy with NSAIDs and systemic corticosteroids. RoACTEMRA^® is also used to treat chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults or paediatric patients 2 years of age or older, and severe coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. The MAA includes positive Phase 3² data for BIIB800 from the clinical program of a multicenter, multinational, randomized, double-blind, parallel-group, active-control study, designed to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of BIIB800 compared to RoACTEMRA^® in 621 patients with moderate to severe rheumatoid arthritis with inadequate response to methotrexate. The Phase 3 data from the comparative clinical trial demonstrated that the biosimilar candidate BIIB800 has equivalent efficacy and a comparable PK, safety and immunogenicity profile to reference tocilizumab and these positive results were presented at the European Congress of Rheumatology on June 3, 2022.

“The EMA filing acceptance for BIIB800 brings us a step closer to potentially offering broader patient access to another more affordable and important new biosimilar treatment option in Europe, and we look forward to continued engagement with the EMA throughout the review process,” said Ian Henshaw, Head of Global Biosimilars at Biogen. “If approved, BIIB800 will be a valuable treatment option for people with chronic immune mediated inflammatory diseases. We believe our biosimilar offerings are essential as we collaborate with payers and health authorities with the goal of generating savings to ensure sustainable healthcare systems.”

On April 8^th, 2021, Biogen and Bio-Thera Solutions, Ltd. entered into a commercialization and license agreement to develop, manufacture and commercialize BIIB800. Biogen has exclusive regulatory, manufacturing and commercial rights to BIIB800 in all countries excluding China (including Hong Kong, Macau and Taiwan).

Biosimilars are products that have been demonstrated to be similar in efficacy and safety to the originator’s reference product, with the advantage that they offer cost savings and promote sustainable access to therapies. Biogen is committed to advancing development, manufacturing and commercialization of additional biosimilar candidates with the goal of optimizing the disease management with biosimilars and helping more people and healthcare systems across the world to benefit from biologics treatments.

About Biogen
As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and developed the first and only approved treatment to address a defining pathology of Alzheimer’s disease. Biogen is also commercializing biosimilars and focusing on advancing one of the industry’s most diversified pipelines in neuroscience that will transform the standard of care for patients in several areas of high unmet need.

In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil fuels across the company’s operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities.

We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

Safe Harbor

This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to the potential benefits and results that may be achieved through Biogen’s commercialization and license with Bio-Thera Solutions; the potential benefits, safety and efficacy of BIIB800; risks and uncertainties associated with drug development and commercialization; the potential of Biogen’s commercial business and pipeline programs; Biogen’s strategy and plans; and potential cost healthcare savings related to biosimilars. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, risks that the proposed transaction will not be completed in a timely manner or at all; the possibility that certain closing conditions to the proposed transaction will not be satisfied; uncertainty as to whether the anticipated benefits of the proposed transaction can be achieved; risks of unexpected costs or delays or other unexpected hurdles; uncertainty of success in the development and potential commercialization of BIIB800, which may be impacted by, among other things, unexpected concerns that may arise from additional data or analysis, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, failure to protect and enforce data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; risks of legal actions, regulatory scrutiny or other challenges to biosimilars; the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen’s business, results of operations and financial condition; the risks of doing business internationally, including currency exchange rate fluctuations; product liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

References:

1. ACTEMRA®/RoACTEMRA^® is a registered trademark of Genentech, Inc.
2. https://ard.bmj.com/content/annrheumdis/81/Suppl_1/388.2.full.pdf

MEDIA CONTACT: Biogen Dan Haro + 1 617 914 6936 [email protected]

INVESTOR CONTACT: Biogen Mike Hencke +1 781 464 2442 [email protected]

WALTHAM, Mass., Sept. 30, 2022 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that four oral presentations of data from the Phase 3 DERBY and OAKS studies evaluating pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration will be presented at the American Academy of Ophthalmology (AAO) Annual Meeting on September 30 – October 3 in Chicago, Illinois. Data highlights include detailed 24-month results of safety and efficacy as well as exploratory analyses of lesion growth data and photoreceptor changes utilizing artificial intelligence guided image processing.

“Our scientific presence at AAO this year is a testament to our leadership in retina and the potential of pegcetacoplan to become the first treatment for GA, a devastating disease that leads to irreversible vision loss,” said Federico Grossi, M.D., Ph.D., chief medical officer, Apellis. “We look forward to sharing these data with the ophthalmology community as we work toward bringing pegcetacoplan to patients with GA as quickly as possible.”

The U.S. marketing application for pegcetacoplan for GA is under Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 26, 2022. Apellis plans to submit a marketing authorization application to the European Medicines Agency by the end of this year.

Presentation details:

• Treatment of Geographic Atrophy Secondary to AMD With Pegcetacoplan: Two-Year Outcomes from the Randomized Phase 3 DERBY and OAKS Trials – RET10 – Friday, Sept. 30 – 4:30 – 4:36 p.m. CST
• The Role of AI-Guided OCT Imaging in Geographic Atrophy – RET19 – Saturday, Oct. 1 – 3:13 – 3:19 p.m. CST
• Efficacy of Intravitreal Pegcetacoplan in GA: 24-Month Results from the Phase 3 DERBY and OAKS Trials – PA024 – Sunday, Oct. 2, 8:12 – 8:19 a.m. CST
• Safety of Intravitreal Pegcetacoplan in GA: 24-Month Results from the Phase 3 DERBY and OAKS Trials – PA069 – Sunday, Oct. 2, 4:45 – 4:52 p.m. CST

e-Poster:

• Evaluation of Patients with GA Secondary to AMD: Analysis of the Academy IRIS^® Registry – PO427

About DERBY and OAKS

DERBY (621 patients enrolled) and OAKS (637 patients enrolled) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of intravitreal pegcetacoplan with sham injections in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The primary objective of the studies is to evaluate the efficacy of pegcetacoplan in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence (p-value less than .05) at 12 months. Patients in DERBY and OAKS received masked treatment for 24 months. All patients who completed the DERBY or OAKS studies were invited to participate in the GALE open-label extension study.

About Geographic Atrophy (GA)

Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) and a leading cause of blindness that impacts more than 5 million people worldwide, including one million people in the United States.^1,2 This progressive disease can severely impair visual function, independence, and quality of life as it takes on average 2.5 years for GA lesions to encroach the fovea, which is responsible for central vision.³ GA is caused by destruction of retinal cells through irreversible lesion growth that is driven by excessive complement activation.⁴ C3 is the only target that can precisely control the complement cascade due to its central location. There are currently no approved treatments for GA.

About Pegcetacoplan for Geographic Atrophy (GA)

Pegcetacoplan is an investigational, targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. Pegcetacoplan was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of geographic atrophy.

About Apellis 
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that is committed to leveraging courageous science, creativity, and compassion to deliver life-changing therapies. Leaders in complement, we ushered in the first new class of complement medicine in 15 years with the approval of the first and only targeted C3 therapy. We are advancing this science to continually develop transformative medicines for people living with rare, retinal, and neurological diseases. For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn.

Apellis Forward-Looking Statement 
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding timing of anticipated regulatory submissions. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the results of the FILLY, DERBY and OAKS trials are sufficient to support regulatory submissions; whether a submission for approval of intravitreal pegcetacoplan for GA on the basis of the FILLY, DERBY and OAKS trials will be accepted by the FDA or foreign regulatory agencies; whether intravitreal pegcetacoplan will receive approval from the FDA or equivalent foreign regulatory agencies for GA when expected or at all; and other factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the Securities and Exchange Commission on February 28, 2022 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Media Contact: 
Lissa Pavluk
[email protected]
617.977.6764

Investor Contact: 
Meredith Kaya 
[email protected]
617.599.8178

1 Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta analysis. Ophthalmology 2012;119:571–580. 2 Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–116. 3 Lindblad AS, et al, and AREDS Research Group. Arch Ophthalmol. 2009;127(9):1168-1174. 4 Seddon, JM, Rosner, B. Validated prediction models for macular degeneration progression and predictors of visual acuity loss identify high-risk individuals. Am J Ophthalmol 2019;198:223–261.